Vimpat 50mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Functionalized amino acid; Selective enhancer of slow inactivation of voltage-gated sodium channels
Pregnancy Category
C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lacosamide is a medicine used to treat seizures (epilepsy). It works by calming overactive nerves in the brain that cause seizures. It can be used alone or with other seizure medicines.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, and it's best to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's crucial to maintain your treatment schedule to ensure the best possible outcome.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally responsible way to dispose of your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, and it's best to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's crucial to maintain your treatment schedule to ensure the best possible outcome.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally responsible way to dispose of your medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, do not stop taking suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid driving or operating machinery until you know how this medicine affects you, as it can cause dizziness and vision problems.
- Avoid alcohol, as it can increase side effects like dizziness and drowsiness.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Carry a medical alert card or wear a medical alert bracelet indicating your epilepsy and medication.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: Initial 50 mg twice daily (BID), titrated weekly by 50 mg BID increments to a target dose of 100-200 mg BID (200-400 mg/day). IV: Initial 200 mg single dose, followed by 50 mg BID oral, or 100-200 mg BID IV.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
adjunctive_therapy_partial_onset_seizures:
Initial 50 mg BID, increase by 50 mg BID weekly to target 100-200 mg BID. Max 400 mg/day.
monotherapy_partial_onset_seizures:
Initial 50 mg BID, increase by 50 mg BID weekly to target 100-200 mg BID. Max 400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants <1 month. For 1 month to <4 years: Initial 1.25 mg/kg BID, titrate weekly by 1.25 mg/kg BID increments to target 3-6 mg/kg BID (max 12 mg/kg/day).
Child:
4 years to <17 years: Initial 2.5 mg/kg BID, titrate weekly by 2.5 mg/kg BID increments to target 5-10 mg/kg BID (max 20 mg/kg/day, not to exceed 400 mg/day). For children weighing âĨ50 kg, adult dosing applies.
Adolescent:
âĨ17 years: Adult dosing applies (Initial 50 mg BID, target 100-200 mg BID).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min).
Moderate:
No adjustment needed (CrCl 30-50 mL/min).
Severe:
Maximum recommended dose is 300 mg/day (CrCl â¤30 mL/min).
Dialysis:
Maximum recommended dose is 300 mg/day. A supplemental dose of up to 50% of the daily dose should be considered immediately after hemodialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Maximum recommended dose is 300 mg/day.
Severe:
Not studied. Use with caution, consider lower maximum dose, and monitor closely.
Pharmacology
Mechanism of Action
Lacosamide's precise mechanism of action is not fully understood. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels (VGSCs), leading to stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It also binds to the collapsin response mediator protein 2 (CRMP-2), a phosphoprotein involved in neuronal differentiation and axonal guidance, though the contribution of this binding to its anticonvulsant effect is unclear.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
1-4 hours
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 0.6 L/kg
ProteinBinding:
<15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 0.48 L/h/kg
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 40%
Pharmacodynamics
OnsetOfAction:
Within hours (following initial dose)
PeakEffect:
Steady-state concentrations are achieved in approximately 3 days with twice-daily dosing.
DurationOfAction:
Approximately 12 hours (consistent with BID dosing)
Safety & Warnings
BLACK BOX WARNING
Antiepileptic drugs (AEDs), including Vimpat, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
A rare but potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor immediately:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
Vomiting
Dry mouth
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
A rare but potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor immediately:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
Vomiting
Dry mouth
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or feeling like you might pass out
- Double vision or blurred vision
- Problems with coordination or balance (ataxia)
- Nausea or vomiting that is severe or persistent
- Rash, fever, swollen glands, or swelling in your face (signs of a severe allergic reaction)
- New or worsening depression, anxiety, agitation, panic attacks, trouble sleeping, irritability, hostility, aggressiveness, restlessness, hyperactivity (mentally or physically), or thoughts about suicide or hurting yourself.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
As directed by your doctor, undergo regular blood tests and discuss the results with them. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly. Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac complications and death. If you have concerns, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
As directed by your doctor, undergo regular blood tests and discuss the results with them. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly. Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac complications and death. If you have concerns, discuss them with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia
- Ataxia
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., PR prolongation, AV block)
What to Do:
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and monitoring of vital signs and ECG.
Drug Interactions
Major Interactions
- Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, antiarrhythmics): Concomitant use may increase the risk of PR interval prolongation and cardiac adverse events. ECG monitoring is recommended.
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, fluoxetine, omeprazole): May increase lacosamide plasma concentrations. Dose reduction of lacosamide may be necessary.
- Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort): May decrease lacosamide plasma concentrations. Dose increase of lacosamide may be necessary.
Moderate Interactions
- Other antiepileptic drugs (e.g., carbamazepine, phenytoin): While lacosamide does not significantly affect the pharmacokinetics of most AEDs, some AEDs (e.g., carbamazepine, phenytoin) can induce CYP enzymes that metabolize lacosamide, potentially leading to slightly lower lacosamide levels. Clinical significance is generally minor.
- Oral contraceptives: Lacosamide does not significantly affect the efficacy of oral contraceptives.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline PR interval, especially in patients with pre-existing cardiac conduction problems or those taking other PR-prolonging medications.
Timing: Prior to initiation of therapy.
Renal function (CrCl)
Rationale: To guide initial dosing and dose adjustments in patients with renal impairment.
Timing: Prior to initiation of therapy.
Hepatic function (ALT, AST, bilirubin)
Rationale: To guide initial dosing and dose adjustments in patients with hepatic impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure frequency, improved seizure control
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, nausea, diplopia, ataxia)
Frequency: Regularly, especially during titration and dose changes
Target: Minimization of side effects
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
ECG (PR interval)
Frequency: Periodically, or as clinically indicated
Target: Normal PR interval
Action Threshold: Significant PR prolongation, especially if symptomatic or in patients with cardiac risk factors, warrants further cardiac evaluation and potential dose adjustment/discontinuation.
Mood and behavior changes (e.g., suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose changes
Target: Stable mood, absence of suicidal thoughts/behaviors
Action Threshold: Emergence or worsening of depression, suicidal thoughts, or unusual behavior warrants immediate clinical evaluation.
Symptom Monitoring
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (lack of coordination)
- Tremor
- Fatigue
- Headache
- Suicidal thoughts or behavior
- Signs of hypersensitivity reaction (rash, fever, lymphadenopathy, facial swelling)
Special Patient Groups
Pregnancy
Lacosamide is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, consistent with other AEDs. Data are limited.
Second Trimester:
Continued exposure may affect fetal development.
Third Trimester:
Continued exposure may affect fetal development; potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Lacosamide is excreted into human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother's clinical need for lacosamide, and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and weight gain.
Infant Risk:
L3 (Moderately Safe - Limited data suggest possible risk, but benefits may outweigh risks).
Pediatric Use
Approved for partial-onset seizures in patients 1 month of age and older. Dosing is weight-based and age-dependent. Close monitoring for adverse effects is crucial.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustments based on creatinine clearance. They may also be more susceptible to adverse effects like dizziness and ataxia.
Clinical Information
Clinical Pearls
- Titration is crucial: Start low and go slow to minimize CNS side effects (dizziness, ataxia, diplopia).
- Cardiac monitoring: Be mindful of PR interval prolongation, especially in patients with pre-existing cardiac conduction issues or those on other PR-prolonging medications. An ECG before and during treatment may be warranted.
- Suicidal ideation: Like all AEDs, monitor for changes in mood, behavior, and suicidal thoughts.
- Withdrawal seizures: Do not discontinue abruptly; taper gradually over at least 1 week to avoid increased seizure frequency or status epilepticus.
- IV formulation: An IV formulation is available for situations where oral administration is temporarily not feasible; IV and oral doses are interchangeable.
Alternative Therapies
- Levetiracetam (Keppra)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Phenytoin (Dilantin)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
Varies widely, typically high for brand-name per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient information sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.